Anastomosis sheath and method of use

ABSTRACT

The invention relates a sheath that is affixed to a body lumen, proximal to an anastomosis site. The sheath includes a sleeve defining a passage. A grasping structure is positioned distally of the distal opening of the sheath to facilitate elongation of the sleeve from a first length to a second longer length. A method for using the sheath is also disclosed.

CROSS-REFERENCE TO RELATED APPLICATIONS

The present application claims priority to, and the benefit of, U.S.Provisional Patent Application Ser. No. 61/079,198, filed on Jul. 9,2008, the entire contents of which are hereby incorporated by reference.

TECHNICAL FIELD

The present disclosure relates to a sheath for use with an anastomosisfor prevention of fluid leaks, and more particularly to a sheath whichincludes a grasping structure for extending the sheath distally past ananastomotic site.

BACKGROUND

An anastomosis, or the joining of two vessels, such as portions of theesophagus, colon, or other parts of the digestive tract, is a commonprocedure. Sometimes, however, there are complications associated withthe anastomotic site.

Specific patient populations such as patients with diabetes T1, T2, orother immuno-compromised patients (such as chemotherapy patients) aremore prone to anastomotic leaks. These patient populations have longerhealing profiles and sometimes weaker immune systems and these factorsmay lead to an increase in leak occurrence. Unfortunately, in mostcases, anastomotic leaks are not detected until clinical symptomspresent themselves.

While current anastomotic devices and surgical methods performsatisfactorily, it would be advantageous to provide a device to reducethe risks associated with anastomotic leaks.

SUMMARY

A sheath is described herein which is positioned adjacent an anastomoticsite and provides for protection of an anastomosis and a reduction inanastomotic leaks. The sheath includes a sleeve defining a passage andthe sleeve has a proximal portion and a distal portion. The proximalportion of the sheath is connected to a body lumen proximal to theanastomotic site. The distal portion of the sleeve has a distal opening.The sheath further comprises a grasping structure positioned distally ofthe distal opening, the grasping structure facilitating elongation ofthe sleeve from a first length to a second greater length.

In certain embodiments, the grasping structure is a ring, disc, sutureor mesh. In other embodiments, the grasping structure may be a separatedevice which is attached to the sleeve in vivo such as a suture, staple,or tack. In alternate embodiments, the grasping structure defines anopening. In certain embodiments, the grasping structure is relativelyrigid as compared to the sleeve.

In certain embodiments, the sheath further comprises an extension whichextends distal of the distal opening. The grasping structure isconnected to the extension. In some embodiments, the extension isintegral with the sleeve, yet in other embodiments, the extension issecured to the distal portion of the sleeve. In certain embodiments theextension is curvilinear, triangular or rectangular in shape.

In some embodiments, the sheath comprises a fixation ring which extendscircumferentially around the proximal portion of the sleeve. In otherembodiments, the fixation ring may be relatively rigid compared to thesleeve.

In other embodiments, the sheath may further comprise an active agent, acoating, or a radiopaque marker.

Preferably, the distal portion has an opening which is in fluidcommunication with the passage of the sleeve, enabling the passage offluids through the distal opening of the sheath. In other embodiments,the distal opening defines a circumference and the extension memberextends along an arc length of the circumference.

A method of treating a patient is also provided, comprising the stepsof: providing a sleeve defining a passage and having a distal portion, aproximal portion, a distal opening, and a grasping structure extendingdistally of the distal opening, attaching the proximal portion of thesleeve to a body lumen at a region proximal to an anastomosis site suchthat the distal portion extends distally from the anastomotic site,grasping the grasping structure; and, applying a force to the graspingstructure to thereby elongate the sleeve from a first length to a secondgreater length.

The anastomotic site may be intestinal, vascular, or another body lumen.

BRIEF DESCRIPTION OF THE DRAWINGS

The illustrative embodiments described herein will become more readilyapparent from the following description, reference being made to theaccompanying drawings in which:

FIG. 1A shows a perspective view of a sheath in accordance with a firstembodiment of the present disclosure, the sheath shown in an extendedposition;

FIG. 1B shows a cross-sectional perspective view of a distal opening ofthe sheath of FIG. 1A;

FIG. 2 shows a perspective view of another embodiment of a sheath inaccordance with the present disclosure, the sheath shown in an extendedposition;

FIG. 3 shows a perspective view of another embodiment of a compressedsheath in accordance with the present disclosure, the sheath shown in acompressed position;

FIG. 4 shows a cross-sectional view of another alternate embodiment of asheath in accordance with the present disclosure, the sheath shown in anextended position;

FIG. 5A shows a perspective view of an alternate embodiment of a sheathin accordance with the present disclosure, the sheath shown in anextended position;

FIG. 5B shows a cross-sectional perspective view of a distal opening ofthe sheath of FIG. 5A;

FIG. 6A shows a perspective view of a another embodiment of a sheath inaccordance with the present disclosure, the sheath shown in an extendedposition;

FIG. 6B shows a perspective view of the proximal end portion of thesheath of FIG. 6A; and,

FIG. 7 shows a perspective view of another embodiment of a sheath inaccordance with the present disclosure, the sheath shown in an extendedposition.

DETAILED DESCRIPTION OF EMBODIMENTS

The present disclosure is directed to an anastomotic sheath. The sheathincludes a sleeve having a passage, which allows for the transport andflow of fluids therethrough. A distal portion of the sleeve furtherincludes a grasping structure. A proximal portion of the sleeve isaffixed to a body lumen, proximal to an anastomotic site, enablingfluids to bypass the anastomosis while preventing leakage of luminalcontents. The sleeves are configured for elongation from a first lengthto a second longer length. Sheaths of the present disclosure may be madefrom a variety of materials including both biodegradable andnon-biodegradable materials.

In the description that follows, the term “body lumen” as used herein,means inner open space or cavity of a tubular organ, such as a bloodvessel, intestine, or esophagus. The term “biodegradable” as used hereinrefers to materials which decompose, or lose structural integrity underbody conditions (e.g., enzymatic degradation or hydrolysis). The term“proximal” as used herein, means the portion of the sheath which isnearer to the user, while the term “distal” refers to the portion of thesheath which is further away from the user.

The sheath, at least in part, may be comprised of biodegradablematerials which include both synthetic and natural materials. Suitablesynthetic biodegradable materials include polymers such as those madefrom lactide, glycolide, caprolactone, valerolactone, carbonates (e.g.,trimethylene carbonate, tetramethylene carbonate, and the like),dioxanones (e.g., 1,4-dioxanone), 1,dioxepanones (e.g.,1,4-dioxepan-2-one and 1,5-dioxepan-2-one), ethylene glycol, ethyleneoxide, esteramides, γ-hydroxyvalerate, β-hydroxypropionate,alpha-hydroxy acid, hydroxybuterates, poly(ortho esters), hydroxyalkanoates, tyrosine carbonates, polyimide carbonates, polyiminocarbonates such as poly(bisphenol A-iminocarbonate) andpoly(hydroquinone-iminocarbonate), polyurethanes, polyanhydrides,polymer drugs (e.g., polydiflunisol, polyaspirin, and proteintherapeutics) and copolymers and combinations thereof. Suitable naturalbiodegradable polymers include collagen, cellulose, poly(amino acids),polysaccharides, hyaluronic acid, gut, copolymers and combinationsthereof.

Suitable non-biodegradable materials which may be used to construct thesheath include fluorinated polymers (e.g., fluoroethylenes, propylenes,fluoroPEGs), polyolefins such as polyethylene, polyesters such as polyethylene terepththalate (PET), nylons, polyamides, polyurethanes,silicones, ultra high molecular weight polyethylene (UHMWPE),polybutesters, polyaryletherketone, copolymers and combinations thereof.Additionally, non-biodegradable polymers and monomers may be combinedwith each other and may also be combined with various biodegradablepolymers and monomers to create a composite sheath.

In certain embodiments, sheaths according to the present disclosure maybe constructed at least in part using shape memory polymers. Suitablepolymers used to prepare hard and soft segments of shape memory polymersinclude polycaprolactone, polydioxanone, lactide(poly lactic acid),glycolide(poly glycolic acid), polyacrylates, polyamides, polysiloxanes,polyurethanes, polyether amides, polyurethane/ureas, polyether esters,and urethane/butadiene copolymers and combinations thereof.

In some embodiments, the sheath may comprise metals (e.g., steel ortitanium), metal alloys and the like. In alternate embodiments, thegrasping structure may comprise degradable metals such as degradablemagnesium.

Suitable materials of the present disclosure can be processed within thepurview of those skilled in the art including, but not limited toextrusion, injection molding, compression molding, blow molding, filmblowing, thermoforming, calendaring, spinning, and film casting.

The sheath includes a sleeve which extends distally past an anastomoticsite. In some embodiments, the sleeve is film which may be porous orsemi-permeable to enable or restrict oxygen and nutrient transport. Insome embodiments, semi-permeable or controlled permeability propertiesalong some or all of the sleeve's length allow absorption of certainnutrients at the appropriate location in the body lumen wall. Forexample, when the sheath is used in the intestines, nutrient absorptionat a specific location along the gastrointestinal tract is desirable toavoid malabsorption. Alternately, a specific length or the entire lengthof the sleeve may be non-porous or impermeable. It will be understoodthat other embodiments are within the purview of those skilled in theart and are within the context of the present disclosure. For example,alternate embodiments such as foams or woven fibers may be preferred tofilms when the sleeve's surface area is used to alter the degradationtimes and profiles. It should also be understood that the abovediscussion including a structure's permeability, for example, asemi-permeable membrane or controlled permeability, are not limited to asleeve and may also include additional parts of the sheath. Films of thepresent disclosure may be manufactured using methods within the purviewof those skilled in the art including, but not limited to methods listedabove.

Optionally the sheath can include coatings on its interior and/orexterior to enhance the surface properties of the sheath in clinicallyrelevant manners. As used herein, the term “coating” is not limited toliquids and may also include waxes and solids. For example, a parylenecoating may be used to increase the chemical resistance of the sleevematerial. In other embodiments, lubricious coatings may be applied whichaid in nutrient passage through sheath such as poly ethylene glycols.Coatings may be applied using any method within the purview of thoseskilled in the art.

Additionally, any part of the sheath may include biologically acceptableadditives such as plasticizers, antioxidants, dyes, image-enhancingagents, dilutants, bioactive agents such as pharmaceutical and medicinalagents, and combinations thereof which can be coated on the sheath orimpregnated within the resin or polymer.

Medicinal agents which may be incorporated into the sheath includeantimicrobial agents, anti-virals, anti-fungals, and the like.Antimicrobial agents as used herein is defined by an agent which byitself or through assisting the body (immune system) helps the bodydestroy or resist microorganisms which may be pathogenic (diseasecausing). The term “antimicrobial agent” includes antibiotics, quorumsensing blockers, surfactants, metal ions, antimicrobial proteins andpeptides, antimicrobial polysaccharides, antiseptics, disinfectants,anti-virals, anti-fungals, quorum sensing blockers, and combinationsthereof.

Examples of suitable antiseptics and disinfectants which may be combinedwith the present disclosure include hexachlorophene, cationic biguanideslike chlorhexadine and cyclohexidine, iodine and iodophores likepovidone-iodine, halo-substituted phenolic compounds like PCMX (e.g.,p-chloro-m-xylenon) and triclosan (e.g.,2,4,4′-trichloro-2′hydroxy-diphenylether), furan medical preparationslike nitrofurantoin and nitrofurazone, methanamine, aldehydes likegluteraldehyde and formaldehyde, alcohols, combinations thereof, and thelike. In some embodiments, at least one of the antimicrobial agents maybe an antiseptic, such as triclosan.

Classes of antibiotics that can be combined with the present disclosureinclude tetracyclines like minocycline, rifamycins like rifampin,macrolides like erythromycin, penicillins like nafcillin, cephalosporinslike cefazolon, beta-lactam antibiotics like imipenen and aztreonam,aminoglycosides like gentamicin and TOBRAMYCIN®, chloramphenicol,sulfonamides like sulfamethoxazole, glycopeptides like vancomycin,quilones like ciproflaxin, fusidic acid, trimethoprim, metronidazole,clindamycin, mupirocin, polyenes like amphotericin B, azoles likefluconazole, and beta-lactam inhibitors like sublactam. Otherantimicrobials which may be added include, for example antimicrobialpeptides and/or proteins, antimicrobial polysaccharides, quorum sensingblockers (e.g., brominated furanones), anti-virals, metal ions such asionic silver and ionic silver glass, surfactants, chemotherapeutic drug,telomerase inhibitors, other cyclic monomers including 5-cyclicmonomers, mitoxantrone, and the like.

In some embodiments, suitable bioactive agents which may be used includecolorants, dyes, preservatives, protein and peptide preparations,protein therapeutics, polysaccharides such as hyaluronic acid, lectins,lipids, probiotics, angiogenic agents, anti-thrombotics, anti-clottingagents, clotting agents, analgesics, anesthetics, wound repair agents,chemotherapeutics, biologics, anti-inflammatory agents,anti-proliferatives, diagnostic agents, antipyretic, antiphlogistic andanalgesic agents, vasodilators, antihypertensive and antiarrhythmicagents, hypotensive agents, antitussive agents, antineoplastics, localanesthetics, hormone preparations, antiasthmatic and antiallergicagents, antihistaminics, anticoagulants, antispasmodics, cerebralcirculation and metabolism improvers, antidepressant and antianxietyagents, vitamin D preparations, hypoglycemic agents, antiulcer agents,hypnotics, antibiotics, antifungal agents, sedative agents,bronchodilator agents, antiviral agents, dysuric agents, brominated orhalogenated furanones, and the like. In embodiments, polymer drugs,i.e., polymeric forms of such compounds for example, polymericantibiotics, polymeric antiseptics, polymeric chemotherapeutics,polymeric anti-proliferatives, polymeric antiseptics, polymericnon-steroidal anti-inflammatory drugs (NSAIDS), and the like may beutilized and combinations thereof.

In certain embodiments, sheaths of the present disclosure may containsuitable medicinal agents such as viruses and cells, peptides,polypeptides and proteins, analogs, muteins, and active fragmentsthereof, such as immunoglobulins, antibodies (monoclonal andpolyclonal), cytokines (e.g., lymphokines, monokines, chemokines), bloodclotting factors, hemopoietic factors, interleukins (IL-2, IL-3, IL-4,IL-6), interferons (β-IFN, α-IFN and γ-IFN), erythropoietin, nucleases,tumor necrosis factor, colony stimulating factors (e.g., GCSF, GM-CSF,MCSF), insulin, anti-tumor agents and tumor suppressors, blood proteins,gonadotropins (e.g., FSH, LH, CG, etc.) hormones and hormone analogs(e.g., growth hormone), vaccines (e.g., tumoral, bacterial and viralantigens), somatostatin, antigens, blood coagulation factors, growthfactors, protein inhibitors, protein antagonists, and protein agonists,nucleic acids, such as antisense molecules, DNA, RNA, oligonucleotides,polynucleotides and ribozymes and combinations thereof.

In some embodiments, additives such as image-enhancing agents (e.g.,contrast agents) and more specifically, radiopaque markers, may beincorporated into the sheath. These image-enhancing agents enablevisualization of the sheath (against surrounding tissue), when imaged orscanned through different filters such as MRI, X-ray, fluoroscopy, CT,various light sources, and the like. In order to be opaque (andvisualized in certain filters), the sheath must be made from a materialpossessing a radiographic density higher than the surrounding hosttissue and have sufficient thickness to affect the transmission ofx-rays to produce contrast in the image. Useful image-enhancing agentsinclude but are not limited to radiopaque markers such as tantalum,barium sulfate, bismuth trioxide, bromine, iodide, titanium oxide,zirconium, barium, titanium, bismuth, iodine, nickel, iron, silver, andcombinations thereof. In some embodiments, compounds such as tantalum,platinum, barium and bismuth may be incorporated into the sheath. Oftenimage-enhancing agents are not bioabsorbable or degradable but areexcreted from the body or stored in the body.

In some embodiments, image-enhancing agents may be compounded into thematerials (e.g., resin) as filler prior to processing includingextrusion or molding. These agents may be added in variousconcentrations to maximize polymer processing while maximizing thematerial characteristics of the sheath. The biocompatible agents can beadded in quantities sufficient to enhance radiopacity while maintainingthe polymer's properties. In certain embodiments, image-enhancing agentsmay be incorporated into a biodegradable portion, enabling surgeons tovisualize when the biodegradable portion has degraded.

Methods for combining the above mentioned bioactive agents withmaterials of the present disclosure are within the purview of thoseskilled in the art and include, but are not limited to mixing, blending,compounding, spraying, wicking, solvent evaporating, dipping, brushing,vapor deposition, coextrusion, capillary wicking, film casting, moldingand the like. Additionally, solvents may be used to incorporate variousagents into the composite device. Suitable solvents include those listedbelow.

One embodiment of a sheath 10 is illustrated in FIGS. 1A and 1B. Thesheath 10 includes a sleeve 12, an extension 16, and a graspingstructure 18. The sleeve 12 has a proximal portion 12 a and a distalportion 12 b. The sleeve 12 is generally cylindrical in shape, having adiameter “d1” and a corresponding radius “r1” at a proximal opening 14 aand having a diameter “d2,” and radius “r2” at a distal opening 14 b. Incertain embodiments, d1 is of a similar diameter to d2.

As illustrated in FIG. 1B, the extension 16 extends distal from thedistal opening 14 b and extends circumferentially along an arc length“L” or (a segment of a circumference) of the distal opening 14 b. Thearc length “L” is defined as L=θr. As illustrated, angle θ is no greaterthan about 180°. In other words, the extension 16 extends no greaterthan half of the circumference of the distal opening 14 b. In preferredembodiments, the extension 16 extends circumferentially around thedistal opening 14 b where the angle θ may be about 30° to about 270°.The extension 16 is shown generally triangular in shape, however, othershapes are envisioned, including curvilinear, elliptical, rectangular,polygonal, etc. In preferred embodiments, the extension 16 may have agenerally elongate body and be of a similar structure and material tothe sleeve, for example, a polymeric film.

As illustrated in FIGS. 1A-1B, the grasping structure 18 can be a ringthat is disposed in mechanical cooperation with the extension 16 forfacilitating elongation/extension of the sleeve 12. In otherembodiments, the grasping structure 18 may be a mesh, disc, or O-ring.In certain embodiments, the grasping structure 18 may be of any shapewhich defines an opening (e.g. ring). Suitable materials for thegrasping structure 18 include rigid (as compared to sleeve 12) andflexible materials which may be either biodegradable ornon-biodegradable materials such as those metals and polymers listedabove. It should be noted that the various grasping structures disclosedherein may be used with any of the disclosed sheath embodiments.

From FIG. 2, one embodiment of a sheath 20 includes an extension 22 anda sleeve 12. The extension 22 is attached to a distal end 12 b of thesleeve 12. The extension 22 comprises one or more fibers 22 a, 22 b, 22c, etc., by way of example, it being understood that fibers are notlimiting and other extension structures disclosed herein may function ina similar manner such as sutures, tabs and the like. The extension 22may be a variety of shapes, including, but not limited to curvilinear,triangular or rectangular, etc.

With continued reference to FIG. 2, the sheath 20 further includes agrasping structure 18 extending distal from the distal end 12 b of thesleeve 12. Various embodiments of grasping structures 18 arecontemplated for grasping by the user to elongate the sleeve 12 in themanner described herein. In alternate embodiments, the graspingstructure 18 may extend circumferentially around a distal opening 14 bof the sleeve 12. Those within the purview of those skilled in the artcan envision other areas of the sheath 20 suitable for placement of thegrasping structure 18.

FIG. 3 illustrates another embodiment of a sheath 30 disposed in acompressed position, by way of example, it being understood that othersheaths disclosed herein can be similarly inserted in a compressedposition and extended to an elongated position (see e.g., FIG. 2). Inthis embodiment, the sheath 30 includes a sleeve 12, a proximal orfixation ring 32, a distal ring 34, and a grasping structure 18. Onceinserted into a body lumen, the fixation ring 32, applies a radial forceto the body lumen, mounting the proximal portion of the sheath 30 inplace. The distal ring 34 is disposed in mechanical cooperation with thegrasping structure 18. As such, the grasping structure 18 may be graspedby a surgical device “D”, such as a grasper, which applies a downwardforce to the grasping structure 18 (as viewed in the orientation of FIG.3) and pulls the sleeve 12 distally, elongating the length of the sleeve12, and extending the coverage of the sheath 30 distally past theanastomotic site (as viewed in FIG. 4).

Additionally, once the sleeve 12 is elongated, the grasping structure 18may further assist the user in positioning the sheath 30 in the bodylumen “BL” without damaging the sleeve 12. The surgeon may grasp thegrasping structure 18 and distally pull the grasping structure 18 withenough force to move the sheath 30, repositioning the sheath 30 inplace.

In certain embodiments, the grasping structure may be attached to thesleeve via various mechanical and chemical methods within the purview ofthose skilled in the art. Methods include but are not limited to heatmelding/melt pressing, glues/adhesives, solvent welding, ultrasonicenergy, extrusion (e.g., co-extrusion or compound extrusion), overmolding, suturing, stapling or tacking. In some embodiments,glues/adhesives include but are not limited to cyanoacrylates,urethanes, and siloxanes.

Suitable solvents for use in solvent welding include but are not limitedto polar and non-polar solvents such as alcohols, e.g., methanol,ethanol, propanol, chlorinated hydrocarbons (such as methylene chloride,chloroform, 1,2-dichloro-ethane), and aliphatic hydrocarbons such ashexane, heptene, and ethyl acetate.

With reference to FIG. 4, another embodiment of a sheath 40 includes agrasping structure 42 that may be a separate device that is attached toan extension 44 of the sleeve 12 in situ, such as a suture, staple, ortack. Once the sheath 40 is inserted, the proximal end of the sheath 40may be attached to the body lumen “BL” using staples “S”, although othermethods for attachment are contemplated. The grasping structure 42 maythen be attached to the sleeve 12 in the operating room, or in vivo,while the sheath 40 is in the body lumen “BL.” Once the graspingstructure 42 is attached to the extension 44, the grasping structure 42functions in the same manner described above. The grasping structure 42can be distally pulled, which in turn, extends and elongates a portionof the sleeve 12 and the extension 44, distally past the anastomoticsite “A.” In this embodiment, once the sheath 40 is positioned in thebody lumen “BL”, the grasping structure 42 may then be used to mount thesheath 40 to the body lumen “BL.”

FIGS. 5A-5B show an alternate embodiment of a sheath 50 having two ormore different diameters, “d1′,” and “d2′.” The sheath 50 includes asleeve 52, an extension 54 and a grasping structure 56. The sleeve 52narrows in diameter, towards the distal end 52 b of the sleeve 52,resulting in “d1′” having a larger diameter than “d2′.” The extension 54is generally curvilinear and is integral with the distal end 52 b of thesleeve 52. As shown in FIG. 5B, angle θ′ is about 90 degrees, and theextension 54 extends at an arc length “L′” of no greater than about onequarter of the circumference of a distal opening 58 b. However, theextension 54 may extend at a greater or lesser arc length “L1′.” Thegrasping structure 56 is shown interior to the extension 54, in FIGS. 5Aand 5B. The grasping structure 56 is spaced adjacent the distal mostedge 55 of the extension 54. The grasping structure 56 is illustrated asa ring.

Another embodiment of a sheath 60 is shown in FIGS. 6A and 6B. Thesheath 60 includes a sleeve 62, an extension 64, and a graspingstructure 66. The sleeve 62 includes a proximal end 62 a disposed inmechanical cooperation with a fixation ring 68. The fixation ring 68 maybe of a defined length “b” along a longitudinal axis “Y” of the sleeve62 and of a defined wall thickness “a”, as shown in FIG. 6B. The wallthickness “a” may be defined as the length between an inner diameter“di” and an outer diameter “do.” Wall thickness “a” of the fixation ring68 may or may not be similar to wall thickness “c” of the sleeve 62. Ina preferred embodiment, wall thickness “c” of sleeve 62 is less thanwall thickness “a” of fixation ring 68, lending a higher stiffness andrigidity to the fixation ring 68 as compared to the sleeve 62.

The fixation ring 68 provides mechanical support and stiffness to theproximal portion 62 a of the sleeve 62. An increased stiffness andrigidity enables the fixation ring 68 to apply radial pressure to thelumen wall, securing the sheath 60 in place, proximal to the anastomoticsite. In some embodiments, the fixation ring 68 is relatively rigid ascompared to the sleeve 62. In certain embodiments, the fixation ring 68may be used in combination with other devices such as sutures, staplesand glues when mounting the sheath 60 to the lumen wall.

Fixation rings 68 may be made from suitable materials within the purviewof those skilled in the art including polymers and metals such as thoselisted above. In one embodiment, the fixation ring 68 may be made ofpolyurethane or silicone. In an alternate embodiment, the fixation ring68 may be an overmold of a polymer such as lactide or glycolide aroundthe proximal portion 62 a of the sleeve 62.

The fixation ring 68 may be attached to the sleeve 62 via variousmechanical and chemical means within the purview of those skilled in theart, including similar means for attaching the grasping structure 66.The fixation ring 68 may be used with any of the embodiments disclosedherein.

In some embodiments, the fixation ring 68 may additionally usemechanical or chemical methods for securing the fixation ring 68 to thebody lumen; such methods include but are not limited to glues, tacks,sutures, staples, stents, and rings.

The grasping structure 66 is disposed in mechanical cooperation with tothe extension 64. The extension 64 is shown as generally rectangular inshape. The grasping structure 66 may be created by cutting into theextension 64 and removing a portion of the extension 64, defining anopening in the extension 64. As illustrated, the extension 64 may beintegrally formed with the sleeve 62.

Another embodiment of the sheath 70 is shown in FIG. 7. Sheath 70 issimilar to previously described embodiments, including the features of afixation ring 68, a sleeve 12, and the grasping structure 18. However,in this embodiment, the sheath 70 does not have an extension. In otherwords, the grasping structure 18 is disposed in mechanical cooperationwith the sleeve 12. The grasping structure 18 is not limited to a ring(as illustrated in FIG. 7) and may include other structures previouslydescribed. It should be understood that although the sheath 70 does nothave an extension, the sheath 70 is inserted and elongated in a similarmanner to the above-described figures.

In certain embodiments, the sheath is generally tubular in shape andextends along a longitudinal axis of a body lumen. Other shapes areenvisioned including but not limited to shapes such as elliptical,conical and rectangular. Shapes of sheaths in addition to concavity ofthe sheaths of the present disclosure may vary depending on factors suchas the method of use and patient anatomy.

Various degradation profiles and times are contemplated for anybiodegradable portion of the sheath. For example, in one embodiment, thesleeve is comprised of a biodegradable material which may have apersistence time of 1 day to 12 weeks, in embodiments 3 days to 21 days.In some embodiments, mass loss corresponds closely to strength loss ofthe biodegradable portion, hence when the sheath loses mechanicalproperties of the biodegradable portion, the mass of material remainingwill be minimal such as to mitigate inflammation and encapsulation.

The sheath is affixed to the body lumen wall proximal to an anastomosissite before, during, or after anastomosis creation. In severalembodiments, sheaths may be inserted into the body cavity and body lumeneither in an expanded form or a collapsed/compressed position as shownin FIG. 2. Once expanded to the body lumen, the sheath enables fluids tobypass the anastomosis, reducing the amount of fluid contact with theanastomotic site and therefore reducing the potential for anastomoticleaks into the surrounding environment. In some embodiments, an invertedsheath may be inserted into the body lumen, attached to the body lumenwall, and then extended through the body lumen, distal to theanastomotic site. In one example, when used in the colon or intestinaltract, sheaths of the present disclosure may be useful for preventingnutrient absorption for controlling T2 diabetes.

In alternate embodiments, for example, when the sheath is used in theintestinal tract, it is desirable to have the sheath flexible enough soas to allow the peristaltic motions of the intestines to effect movementof food through the composite sheath. However, there should be enoughfriction between the sheath and gastrointestinal tract so thatperistalsis will act to straighten the sheath and apply a small amountof tension to keep the sheath in place.

Preferably, the sheath has a proper balance of mechanical propertiessuch that the sheath maintains coverage over the anastomosis whileextending distally into the body lumen. The sheath preferably maintainsa certain amount of rigidity such that the sheath does not climbproximally or fold on itself, exposing the anastomosis site. Inalternate embodiments, the surface of the sheath may be configured withsmall bumps or other surface features which will enhance the frictionbetween the sheath and the body lumen.

It should be noted that the present disclosure is not limited to usewith colonic and intestinal anastomoses and contemplates use at otheranastomotic sites such as vascular anastomoses. Additionally, the abovedescription contains many specifics; these specifics should not beconstrued as limitations on the scope of the disclosure herein butmerely as exemplifications of particularly useful embodiments thereof.Those skilled in the art will envision many other possibilities withinthe scope and spirit of the disclosure as defined by the claims appendedhereto.

What is claimed is:
 1. A sheath for positioning within a body lumenadjacent an anastomotic site, the sheath comprising: a skin formed of atleast one of a film and a foam, the skin including a proximal-most endand a distal-most end defining a passage therebetween, the distal-mostend defining a distal opening, the distal opening being the most distalopening of the sheath that is substantially coaxially aligned with thepassage, the proximal-most end being insertable in the body lumen andpositionable spaced apart from the anastomotic site; and a graspingstructure positioned distally of the distal opening and the distal-mostend of the skin, the grasping structure including a proximal end and adistal end, the grasping structure defining an aperture therethroughthat is disposed between the proximal and distal end of the graspingstructure, the grasping structure facilitating elongation of the skinfrom a first length to a second longer length, the entire proximal endof the grasping structure being fixedly secured to the skin continuouslyalong a segment of a circumference of the skin that is defined about thedistal opening of the skin.
 2. The sheath of claim 1, wherein thegrasping structure includes a ring, disc, suture, or mesh.
 3. The sheathof claim 1, wherein the grasping structure is a ring.
 4. The sheath ofclaim 1, wherein the grasping structure is a separate device which isattached to the skin in vivo.
 5. The sheath of claim 4, wherein thegrasping structure includes a suture, staple, or tack.
 6. The sheath ofclaim 1, wherein the grasping structure includes an extension whichextends from the skin along the segment of the circumference of theskin, the aperture extending through the extension.
 7. The sheath ofclaim 6, wherein the extension is integral with the skin.
 8. The sheathof claim 6, wherein the extension has a shape defined by at least one ofcurvilinear, triangular, or rectangular.
 9. The sheath of claim 1,wherein the grasping structure is relatively rigid as compared to theskin.
 10. The sheath of claim 1, wherein the sheath further comprises afixation ring which extends circumferentially around the proximalportion of the skin.
 11. The sheath of claim 10, wherein the fixationring is relatively rigid compared to the skin.
 12. The sheath of claim1, wherein the anastomotic site is at least one of intestinal orvascular.
 13. The sheath of claim 1, wherein the distal opening is incommunication with the passage of the skin, enabling the passage offluids through the distal opening of the skin.
 14. The sheath of claim1, wherein the sheath further comprises an active agent.
 15. The sheathof claim 1, wherein the sheath further comprises a coating.
 16. Thesheath of claim 1, wherein the sheath further comprises a radiopaquemarker.
 17. The sheath according to claim 1, wherein the aperture isdisposed transverse to the distal opening.
 18. A sheath for positioningwithin a lumen adjacent an anastomotic site comprising: a sleeve formedof at least one of a film and foam, the sleeve including a proximalportion and a distal portion defining a passage therebetween, theproximal portion being configured for inserting in the lumen andconfigured to be spaced apart from the anastomotic site, the distalportion having a distal opening defining a circumference, the distalopening being the most distal opening of the sheath that issubstantially coaxially aligned with the passage, the distal portionincluding an extension, the extension extending distally from the sleevebeyond the distal opening along an arc length of the circumference; anda grasping structure integrally and fixedly secured within theextension.
 19. The sheath according to claim 18, wherein the skin isnon-porous.
 20. The sheath according to claim 18, wherein the graspingstructure defines an aperture therethrough, the aperture being disposedtransverse to the distal opening.
 21. A sheath for positioning within alumen adjacent an anastomotic site comprising: a sleeve including aproximal portion and a distal portion defining a passage therebetween,the proximal portion being configured for inserting in the lumen andconfigured to be spaced apart from the anastomotic site, the distalportion including a distal-most end and having a distal opening defininga circumference, where the distal opening is the most distal opening ofthe sheath that is substantially coaxially aligned with the passage; thedistal portion including an extension, the extension extending distallyfrom the sleeve beyond the distal opening along an arc length of thecircumference; and a grasping structure secured within the extension andenclosed by the extension.
 22. The sheath of claim 21, wherein thesleeve is formed of at least one of a film and a foam.